Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01847417 | Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions | PHASE1 | COMPLETED | 24 | — | — | May 16, 2013 | Jul 1, 2013 | Jul 13, 2017 | 1 | India |
| NCT01847404 | Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of ASA (Acetylsalicylic Acid) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | May 14, 2013 | Jun 28, 2013 | Jul 13, 2017 | 1 | India |
The bioavailability of two test products was compared with the reference products after determining the plasma PK parameters: Cmax (maximum measured plasma concentration), Tmax (time of Cmax), AUC0-t (area under the plasma concentration versus time curve from time zero to the last measurable concentration), AUC0-infinity (AUC from zero to infinity), t1/2 (time required for the plasma drug concentration to decrease by one half), Kel (terminal rate constant) and AUC\_% Extrap\_Obs (residual area in percentage determined by formula) for ASA and pantoprazole in relevant treatments
| Arm | Type | Description |
|---|---|---|
| Overall Study Arm | EXPERIMENTAL | All the subjects in this study will take part in 3 treatment periods with one of the following treatments in each period. Subjects will receive all three treatments (one per period) in a random order in fed condition. Test 1= Fixed dose combination (FDC) formulation one of a capsule containing ASA 100 mg and pantoprazole 20 mg. Test 2= FDC formulation two of a capsule containing ASA 100 mg and pantoprazole 20 mg. Reference= ASA 100 mg tablet + pantoprazole 20 mg gastro-resistant tablet |
| Name | Type | Description |
|---|---|---|
| Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one | DRUG | Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK |
| Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two | DRUG | Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK |
| ASA 100 mg tablet | DRUG | Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany |
| Pantoprazole 20 mg gastro-resistant tablet | DRUG | Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany |
Inclusion criteria: * Healthy human subjects within the age range of 18 to 45 years (both inclusive) * Non-smokers since at least six months * Willingness to provide written informed consent to participate in the study * Body-mass index (BMI) of \>=18.5 kilogram per meter square (kg/m\^2) and \<=24...